Association of Nutritional Status With Immune Checkpoint Inhibitor Efficacy in Metastatic Metastatic Esophagogastric Cancer.

NCT06923020 | Enrolling By Invitation DMC

• 1 other identifier: Nutrition EGC-2024-KY-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with advanced gastrointestinal cancers, malnutrition can lead to increased incidence of adverse events during the peri-chemoradiotherapy period, reduced treatment tolerance, lower completion rates of therapy, compromised efficacy and quality of life, and ultimately shortened survival. Currently, immunotherapy represented by PD-1 inhibitors has become a cornerstone in the treatment of advanced gastrointestinal cancers. Nutritional status plays a critical role in malignancies, with the Prognostic Nutritional Index (PNI) and Controlling Nutritional Status (CONUT) score being particularly important for assessing nutritional conditions in cancer patients. Gastrointestinal cancers, as a group of heterogeneous tumors with distinct morphological and molecular genetic features, are closely linked to nutritional status. Peripheral blood cell profiles reflect the inflammatory impact of malignancies and immune responses in patients, which are crucial for determining treatment responses and clinical outcomes to enable early stratification, intervention, and monitoring. Therefore, this study aims to explore the clinical significance of nutrition-related prognostic indicators in immunotherapy by evaluating nutritional status and comparing treatment efficacy of first-line immune checkpoint inhibitors among advanced gastric cancer and esophageal cancer patients (including unresectable locally advanced, recurrent, or metastatic gastrointestinal cancers such as gastric/gastroesophageal junction adenocarcinoma and esophageal carcinoma) with different nutritional profiles.

Conditions

Gastric Neoplasm; Esophageal Adenosquamous Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.

  5 years

Secondary Outcomes (1)

• Progression-free survival (PFS)

  3 years

Study Arms (2)

Cohort A

advanced GC patients receiving first-line ICIs

Other: Exposure: Nutritional Status

Cohort B

advanced ESCC patients receiving first-line ICIs

Other: Exposure: Nutritional Status

Interventions

Exposure: Nutritional Status OTHER

The assessment of nutritional risk screening (NRS) and nutritional assessments were conducted using NRS 2002 and Patient-Generated Subjective Global Assessment (PG-SGA).

Cohort A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic ESCC and GC patients receiving the first-line therapy ICIs

You may qualify if:

• Histologically confirmed esophageal squamous carcinoma and gastric adenocarcinoma, metastatic disease.
• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
• Karnofsky performance status ≥80
• Life expectancy of ≥ 3 month
• WBC \> 3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 2.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.5 times ULN
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
• Normal ECG and heart function
• Fertile patients must use effective contraception
• Good compliance

You may not qualify if:

• Previous treatment of palliative chemotherapy
• Only with Brain or bone metastasis
• No measurable lesions, eg. pleural fluid and ascites
• Suffer from severe heart disease or disease with other important organs
• Chronic diarrhea or renal dysfunction
• Pregnancy or lactation period
• Other previous malignancy within 5 year, except non-melanoma skin cancer Chronic diarrhea
• Mentally abnormal or disable cognition,including CNS metastasis

Sponsors & Collaborators

• Yongxu Jia: lead

Study Sites (1)

Yongxu Jia

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 11, 2025
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CN (1)